Gibbons Law Alert
In Covis Pharma GmbH v. Eugia Pharma Specialties Ltd. [LINK 1], the United States District Court for the District of Delaware recently granted both the Plaintiffs’ and Defendants’ requests to stay the litigation, but denied the Plaintiffs’ additional request to toll the statutory 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii).
In Razor USA LLC v. DGL Group, Ltd., the United States District Court for the District of New Jersey recently denied a defendant’s motion to amend its invalidity contentions to include an additional written description argument. The case involves utility and design patents pertaining to a hoverboard. After learning that the design patent issued with drawings had previously been rejected by the Patent and Trademark Office (PTO) (as opposed to those that the PTO later approved), the defendant sought to add an argument that the design patent was invalid pursuant to 35 U.S.C. § 112(a) for the same reasons that the PTO had previously rejected the published drawings. The defendant asserted that it learned about this “new” defense after the plaintiff’s expert stated in a declaration that he had reviewed the prosecution history of the design patent, which prompted the defendant’s own investigation of the prosecution history. In evaluating whether the defendant’s application met the requirements of Local Patent Rule 3.7, the court looked to the defendant’s diligence and the timeliness of the motion. The court concluded that both were lacking. With respect to diligence, the “dominant consideration” in the motion to amend, the court concluded that the defendant had failed to act with the requisite diligence in discovering the information it sought to add...
In MicroVention, Inc. v. Balt USA, LLC, the United States District Court for the Central District of California recently denied a defendant’s motion to amend its invalidity contentions to add additional written description and enablement arguments, finding a lack of diligence by the defendant. The court, which in patent cases “follows a schedule similar to that imposed by the Northern District of California,” emphasized the diligence that must be shown to warrant a party amending its invalidity contentions. Specifically, the court noted that “‘[t]he critical issue is not when [the party] discovered [the] information, but rather whether [it] could have discovered it earlier had it acted with the requisite diligence.’” (quoting Google, Inc. v. Netlist Inc., 2020 WL 1838693, at *2 (N.D. Cal. May 5, 2010)). As we recently reported, the District of New Jersey “adopted verbatim [its] Local Patent Rules from the Northern District of California.” TFH Publ’n, Inc. v. Doskocil Mfg. Co., 705 F. Supp. 2d 361, 365 (D.N.J. 2010). The court found that one of the defendant’s proposed amendments was based on the claim construction position the plaintiff had taken during the claim construction phase of the case. However, the court recognized that the plaintiff’s claim construction had not changed since the beginning of the case and, on that basis, found that...
The United States District Court for the Central District of California recently granted a plaintiff’s motion to strike portions of the defendant’s expert report for the untimely disclosure of new invalidity theories that were not previously disclosed in the defendant’s invalidity contentions. In Nichia Corporation v. Feit Electric Company, Inc., the plaintiff sought to strike from the defendant’s expert report: (1) an entirely new reference; (2) two new obviousness theories based on combinations of references not included in the defendant’s final invalidity contentions; and (3) a new written description argument. In ruling, the court highlighted the district’s Standing Patent Rules’ emphasis on “early notice” of infringement and validity contentions, that amendments to contentions require diligence by the moving party and that new infringement and invalidity theories cannot be introduced through expert reports. The Standing Patent Rules that the parties were following were initially set forth by Judge Guilford of the Central District of California. It has been noted that “Judge Guilford’s Standing Patent Rules are similar to the Local Patent Rules adopted by the Northern District of California.” Mort. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1321(Fed. Cir. 2016). And, relatedly, the District of New Jersey “adopted verbatim [its] Local Patent Rules from the Northern District of California.” TFH Publ’n, Inc....
In an interesting decision applying California’s Local Patent Rules, Northern District of California District Court Judge William Alsup held that “after receiving the other side’s preliminary claim construction disclosure under Rule 4-2, a party in a patent litigation must move promptly to disclose any back-up contentions it may wish (or eventually wish) to make for its infringement or invalidity case, in the event the other side’s claim construction is thereafter adopted or else any such back-up contentions will be deemed waived. Promptly means within 28 days at the latest.” Fluidigm Corp., et al. v. IONpath, Inc. at 4. Judge Alsup’s decision was his answer to “the question of the extent to which our patent local rules require infringement and invalidity contentions to set forth not only a party’s primary theory but also its backup theory in case its opponent’s claim construction prevails.” Id. at 1. In answering that question, Judge Alsup provided a brief exposition on California’s Local Patent Rules. “Before our local patent rules, parties struggled to determine the opposing party’s theory of liability via discovery requests, such as contentions interrogatories.” Id. at 6. The adoption of local patent rules “replaced the bone-crushing burden of scrutinizing and investigating discovery responses with the parties’ infringement and invalidity contentions.” In alleviating that burden, local patent rules...
In a significant Hatch-Waxman decision, a Delaware District Court recently denied the defendants’ motion to dismiss under Federal Rule of Civil Procedure 12(b)(1), rejecting the argument that the conversion of the defendants’ Paragraph IV certifications to Paragraph III certifications deprived the court of subject matter jurisdiction, but granted the defendants’ motion for partial judgment on the pleadings under Federal Rule of Civil Procedure 12(c). In H. Lundbeck A/S v. Apotex Inc., the defendants converted their Paragraph IV certifications for certain patents at issue to Paragraph III certifications. Under 21 U.S.C. § 355(j)(2)(A)(viii), an ANDA filer must make any one of four (I-IV) certifications for each Orange Book listed patent. A Paragraph IV certification is an ANDA filer’s statement that it intends to market its bioequivalent pharmaceutical product before the expiration of a patent listed as covering that product because the ANDA filer believes such patent is either not infringed or invalid. A Paragraph III certification is an ANDA filer’s statement that it will not market its bioequivalent product until after the expiration of a patent listed as covering that product. The Court reasoned that in a Hatch-Waxman action, subject matter jurisdiction exists when a patent owner alleges that the filing of an ANDA infringes its patent under 35 U.S.C. § 271(e)(2) and conversion from a...
In Bio Delivery Sciences International Incorporated v. Alvogen PB Research & Development LLC, a Delaware District Court recently denied the plaintiffs’ motion to strike two prior art references from the defendants’ supplemental invalidity contentions, reasoning that the defendants were not obligated, as the plaintiffs argued, to demonstrate good cause for the amendment. The court noted that the case’s scheduling order did not contain a “good cause” requirement for amending contentions or a requirement that contentions be amended before the date on which the defendants served their amended contentions. The court reasoned that, while the amended contentions did need to comport with the requirements of Fed. R. Civ. P. 26, an analysis under the Pennypack factors did not require striking the references. In particular, the “possibility of curing the prejudice” and “likelihood of disruption of trial” factors militated strongly in the defendants’ favor because the plaintiffs did not need further discovery on the references and could address them easily in their expert reports, which would not have any impact on the trial date. Interestingly, had these defendants been litigating in the District of New Jersey they would have been obligated to demonstrate “good cause,” where Local Patent Rule 3.7 requires a showing of “good cause” for any party to amend “contentions, disclosures, or other documents required...
Applying the plain language of the District of New Jersey’s Local Patent Rules, Chief Judge Wolfson recently ruled in Mitsubishi Tanabe Pharma Corp. v. Sandoz Inc., that the plaintiffs were not precluded from asserting an “invention date” derived from their Local Patent Rule 3.2(b) disclosures that differed from the “priority date” expressly disclosed in their Local Patent Rule 3.1(f) contention disclosures. Local Patent Rule 3.1(f) requires that infringement contentions disclose, “[f]or any patent that claims priority to an earlier application, the priority date to which asserted claim is allegedly entitled.” Local Patent Rule 3.2 governs the document production that must accompany Local Patent Rule 3.1 disclosures and Local Patent Rule 3.2(b) requires the production of “[a]ll documents evidencing the conception, reduction to practice, design, and development of each claimed invention, which were created on or before the date of application for the patent in suit or the priority date identified pursuant to L. Pat. R. 3.1(f), whichever is earlier.” An “invention date” and a “priority date” have distinct meanings in patent law. An “invention date” is the date when the inventor conceived the invention and reduced it to practice and the “priority date” is the filing date of the earliest patent application to which the patents-in-suit are entitled. The plaintiffs’ Local Patent Rule 3.1(f) infringement...
In Genzyme Corp. v. Zydus Pharmaceuticals (USA) Inc., a Delaware district court recently found two patents directed to methods of mobilizing progenitor/stem cells from bone marrow to the peripheral blood stream for use in stem cell transplantation valid under 35 U.S.C. § 101 as being directed to patent-eligible subject matter. The district court utilized the framework articulated in Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014), on which we have previously reported here, here, and here, to determine whether the patent claims covered patent-eligible subject matter or were patent-ineligible “[l]aws of nature, natural phenomena, [or] abstract ideas[.]” Under the Alice framework, the court first determines if the patent claims at issue are directed to a patent-ineligible concept, and, if so, then considers whether the claims contain an “inventive concept” which “transform[s] the nature of the claim into a patent-eligible application.” The district court found that the claims at issue were not directed to any patent-ineligible concept under step one of Alice because they were directed to the patent-eligible concept of “using plerixafor, itself a compound that does not naturally exist, to amplify a natural phenomenon – stem cell mobilization – in an unnatural way.” The court then found that, “even if those claims were directed simply to the natural phenomenon...
In federal cases, venue transfer is permitted pursuant to 28 U.S.C. § 1404(a), “[f]or the convenience of parties and witnesses, in the interest of justice . . . to any other district or division where it might have been brought or to any district or division to which all parties have consented.” The defendants in a patent infringement case venued in the District of New Jersey recently failed in their attempt to transfer venue of their cases to the District of Delaware pursuant to § 1404(a). The cases involve the alleged infringement of a patent that covers Suboxone sublingual film for the treatment of opioid dependence. The defendants argued that venue transfer was appropriate based on their consent to venue in Delaware, the discretionary factors outlined in Jumara v. State Farm Insurance, 55 F.3d 873 (3d Cir. 1995), and the first-filed rule. None of these arguments proved successful, as the magistrate judge issued reports and recommendations denying the motions of defendants Dr. Reddy’s, Teva, and Alvogen Pine Brook. And, the district judge affirmed and adopted the magistrate judge’s opinions. After first concluding that venue for the cases was proper in the District of New Jersey pursuant to the patent venue statue, 28 U.S.C. § 1400(b), the court turned to the defendants’ arguments for transfer. With respect...